Introduction to this report:
Obutinib's revenue in 2023 was 671 million yuan (+18.5%). Clinical progress for hematoma, immunization, and solid tumors is progressing smoothly. Various drugs are expected to be submitted for NDA in 2024. They are optimistic about the company's future development and maintain an “increase” rating.
Summary:
Maintain an “Overweight” rating. The company announced revenue of 739 million yuan in 2023, an increase of 18.1% year on year; net loss of 631 million yuan, a year-on-year decrease of 256 million yuan. Cash and bank balances of $8.22 billion, and cash reserves are abundant. Considering that the dose of obutinib was affected by the tightening of the hospital environment, the 2024-2025 revenue forecast was lowered to 948 million yuan and 1,248 million yuan (originally 10.80 billion yuan and 1,755 million yuan), and the 2026 revenue forecast was added to 1.70 billion yuan, maintaining the “increase” rating.
Obutinib is rapidly dosed, and it is expected that NDA will be submitted within this year for many indications. In 2023, obutinib sold 671 million yuan, an increase of 18.5% over the previous year, thanks to the expansion of r/r MZL new indications and medical insurance coverage for r/rcll/SLL and MCL indications. r/r MCL has completed clinical enrollment and is expected to submit an NDA in 2024Q3; China's 1L CLL/SLL phase III enrollment is expected to be completed, and an NDA is expected to be submitted in 2024Q3; treatment of 1L CLL/SLL with ICP-248 is underway.
Domestic ITP phase III registered clinical trials are expected to complete patient enrollment within 2024; SLE IIb is expected to complete enrollment and mid-term data analysis within 2024. We expect the hematoma field to expand rapidly as the CLL/SLL treatment line of obutinib is raised and MCL is marketed in the US.
The innovative pipeline is progressing smoothly, expanding self-immunity and solid tumor treatment. The company continues to increase investment in R&D, with R&D expenses of 757 million yuan (+16.7%) in 2023, and R&D is progressing smoothly: ① Tafasitamab China's phase II bridging trial to treat r/R DLBCL has completed patient enrollment, and it is expected that BLA will be submitted in 2024Q2. ② ICP332 (TYK2-JH1) has obtained PoC for treating atopic dermatitis. It is expected that phase III will be initiated within this year, and clinical trials of Chinese vitiligo II and US specific dermatitis will be initiated within this year. ③ PoC was obtained by treating psoriasis with ICP488 (TYK2-JH2). Enrollment is expected to be completed in 2024Q2, and Phase II data will be read before the end of 2024. ④ The advanced solid tumor registration clinical trial of ICP-723 (NTRK) is progressing at an accelerated pace, and it is expected that an NDA will be submitted by the end of 2024 or the beginning of 2025.
⑤ ICP-189 (SHP2) combined with the third-generation EGFR inhibitor vormetinib to treat advanced solid tumors completed the first patient enrollment and is expected to receive PoC in 2024.
Catalyst: Sales volume exceeded expectations, R&D progress exceeded expectations.
Risk warning: commercialization capabilities fall short of expectations; R&D falls short of expectations; risk of policy changes.